Current catheters are packaged in such a way that the user is usually required to touch the catheter in order to insert it. The present invention incorporates a controlled tearing line in a catheter package that leaves flaps that can be folded back after the catheter insertion end of the package is torn open to facilitate catheter insertion. In this manner, torn package edges are moved away from the insertion zone and, when extended, the catheter package becomes a urine-receiving sleeve.
Presently, there is significant interest in hydrophilic coated intermittent catheters that are packaged in a manner whereby they are completely ready-to-use as a result of vapor hydration when the catheter reaches the user. In order to accomplish this objective, the catheter's external packaging must be moisture vapor impermeable to maintain a 100 percent relative humidity atmosphere within the package cavity which holds the catheter. By utilizing a moisture vapor impermeable material, it is possible to ensure that the catheter is completely ready-to-use by confining the moisture vapor to the package to thereby prevent the catheter from drying out.
In the present invention, a controlled tearing line is used for opening the package while at the same time being able to utilize a suitably moisture vapor impermeable packaging material. The fact that this material is typically somewhat rigid presents a problem of potentially sharp edges that must not come into contact with the sensitive tissue around the urethra. Also, the controlled tearing line must not be characterized by any tendency to interfere with either the integrity of the sterility of the product or of the moisture vapor impermeability of the package.
In the present invention, the controlled tearing line is advantageously incorporated into the package by using laser scoring. Laser scoring maintains the integrity of product sterility as well as package moisture vapor impermeability by employing a process that utilizes a focused spot of energy to remove material to a specified or desired depth. The laser score lines provide controlled tear propagation while maintaining the package strength and barrier properties.
In order to remove the threat of injury from potentially sharp edges, the laser score lines are designed to leave foldable flaps near the insertion end of the catheter. These flaps can be folded back prior to catheter use to expose the tip of the catheter for insertion into the urethra by griping it through the package. Further, the laser score lines are also designed to cause an opening in the package at the funnel end of the catheter to allow the package to be used as a urine sleeve.
Other objects, advantages and features of the invention will become apparent from a consideration of the following specification taken in conjunction with the accompanying drawings.